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California joins FDA in saying no to CBD in foods, supplements

A position adopted by state officials in California has drawn criticism from companies selling cannabidiol (CBD) in conventional foods and dietary supplements.

The fresh feud brewing in The Golden State symbolizes the disparate treatment of myriad cannabis products in one of the world’s largest economies. Consumers in California can legally buy marijuana for medical and recreational use, but state officials recently said CBD products are off-limits in foods and supplements.

Relying on statements by the federal agency responsible for regulating food in interstate commerce, the Food and Drug Branch of the California Department of Public Health (CDPH) asserted in a public statement, or FAQ, “[T]he use of industrial hemp as a source of CBD to be added to food products is prohibited.”

“Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive or dietary supplement,” the state agency concluded.

According to CDPH’s statement, “California incorporates federal law regarding food additives, dietary use products, food labeling and good manufacturing practices for food.” The CDPH described CBD as “an unapproved food additive” that is not permitted “for use in human and animal foods per the FDA, and thus, it is not approved in California.”

Asked for this article to explain what prompted CDPH to issue the FAQ, the agency noted, “There has been some confusion on the legal use of CBD and CBD oil since the legalization of medicinal and adult-use cannabis in California.”

In 1996, California became the first state to legalize medicinal marijuana through Proposition 215. Earlier this year, the state began permitting recreational sales of cannabis after California, Massachusetts and Nevada in 2016 joined four other states in legalizing recreational marijuana.

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Weighing the pros & cons of supplement delivery forms

Now that you have the perfect formula to add to your product line, what solid dosage delivery form should you choose? Capsules, tablets, softgels or powder? The answer—it depends! This is a decision every brand marketer must make during product design. Each delivery form has its place in the dietary supplement arena. Several factors should be considered when selecting a delivery form to ensure the ingredients are delivered to the body in the most befitting form and the product is convenient and user friendly.

The two-piece hard-shell capsule is the most common delivery form in the supplement space. Most allow a rapid release and require fewer processing aids. Tablets are also widely used, which can be packed with a larger quantity of ingredients, allow time-release delivery and offer a variety of shapes and sizes. A softgel typically consists of a soft gelatin or vegetarian-based shell surrounding a liquid fill. This delivery form is particularly suitable for oil-based ingredients. Powders, as the name implies, consist of a single ingredient or mixture of ingredients in powder form. Powders can be considered the purest of the delivery forms requiring few, if any, processing excipients. Powders are ideal for macronutrients or supplements requiring a large serving size. These solid dosage delivery forms have specific manufacturing processes as well as advantages and disadvantages in form and function.

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Current Good Manufacturing Practices & the Private-Label Distributor

Over the past several years, the Food and Drug Administration (FDA) has focused its attention on compliance issues related to the dietary supplement industry, generally, and on current good manufacturing practices (cGMPs), in particular. Indeed, we have seen an increase in the issuance of 483s and warning letters to Private Label Distributors (PLD) for failing to have adequate standard operating procedures related to cGMPs.

The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated for failure to comply with dietary supplement cGMP requirements (FFDCA § 402(g)). The cGMP regulations are located in Title 21 of the Code of Federal Regulations, Part 111.

To be clear, a PLD is ultimately responsible for products introduced or delivered for introduction into interstate commerce carrying its name and must ensure that the company and products are in compliance with all FFDCA requirements and pertinent regulations. Therefore, along with establishing standard operating procedures (SOPs) the PLD must implement directly, it must also develop oversight SOPs to ensure its contract manufacturing and fulfillment companies are in compliance.

The cGMP regulations provide for broad and general requirements. To the extent that these regulations apply to the PLD, step-by-step how-to instructions and detailed explanations must be identified in the SOPs to implement the cGMP requirement. Below is a broad outline of both the direct and oversight SOPs that a PLD must develop.

Oversight SOPs
As indicated, the agency has issued several warning letters emphasizing the importance of oversight SOPs for dietary supplement cGMPs. The letters stated that a dietary supplement distributor using contract manufacturers or labelers may be liable for cGMP violations by its contractors, explicitly noting that “‘agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever means necessary to ensure compliance with the [FFDCA]’ can be held accountable for violations of the [FFDCA].”

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